Constitutive Study of a Serum Bank and Plasma Bank of Healthy Subjects Comparators to Dialysis Subjects (SPSSCD) (SPSSCD)

November 16, 2021 updated by: Ramsay Générale de Santé
To be able to evaluate the predictive value of glycosylated ferritin as a predictive marker of hepatic iron stock in dialysis patients, we need to validate these results with a cohort of healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This biological collection will include a sample of 2 dry tubes and 2 EDTA tubes. A haematological assessment (CBC, platelets, reticulocytes, Chr (hemoglobin content of reticulocytes), TP-INR, AST, ALT, GGT), measurement of biological markers of iron metabolism (ferritin, serum iron, CRP, transferrin, soluble receptors transferrin, transferrin saturation coefficient) as well as a creatinine assay to validate the normality of renal function in healthy volunteers (GFR established from the MDRD formula), a complete ionogram and a phosphocalcic balance being given the interactions in the dialysis patient (but also in normal subjects) between iron metabolism and phosphocalcic metabolism (calcemia, phosphoremia, PTH, 25OHD3, 1,25OH2D3) will be performed.

We will also study the links between iron overload in dialysis patients and the modulation of the synthesis of parathyroid hormone (intact PTH), FGF23, alpha Klotho and sclerostin.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Quincy-sous-Sénart, France, 91480
        • Hôpital privé Claude Galien

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent
  • Age over 18 years old
  • Healthy volunteers
  • Having given their informed consent in writing
  • Absence of current pathology
  • No current treatment (except contraception)

Exclusion Criteria:

  • Refusal of consent or absence of signature
  • Minor, subject protected by law, (guardianship or curatorship, administrative protection measure)
  • Pregnant woman, parturient
  • Subject suffering from a condition liable to modify his blood parameters

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy volunteers comparators to dialysis subjects
Creation of a biological collection for biological analysis
Biological: Blood sample

Blood test (10 tubes of 5mL) :

- 6 tubes for : complete blood count, platelets, reticulocyte count, TP-INR, AST, ALT, GGT ferritin, serum iron, CRP, transferrin, soluble transferrin receptors, transferrin saturation coefficient enzymatic creatinine, MDRD, ionogram calcemia, phosphoremia, PTH, 25 (OH) D3, 1.25 (OH) 2D3.

2 dry tubes 2 tube EDTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participant with a serum and plasma bank creation
Time Frame: one day
it is only a serum and plasma bank constitution
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramsay Générale de Santé

Collaborators

European Clinical Trial Experts Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2019

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 23, 2019

Study Registration Dates

First Submitted

October 19, 2021

First Submitted That Met QC Criteria

November 16, 2021

First Posted (Actual)

November 17, 2021

Study Record Updates

Last Update Posted (Actual)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-A00040-55

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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